# FDA recall Z-1306-2020

> **Nobel Biocare Usa Llc** · Class II · device recall initiated 2019-03-14.

## Product

Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

## Reason for recall

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

## Distribution

Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.

## Key facts

- **Recall number:** Z-1306-2020
- **Recalling firm:** Nobel Biocare Usa Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-14
- **Report date:** 2020-02-26
- **Termination date:** 2024-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yorba Linda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2020

## Citation

> AI Analytics. FDA recall Z-1306-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-1306-2020. Source: US FDA. Licensed CC0.

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